Summary of the invention
The purpose of this invention is to provide a kind of determined curative effect, few side effects, the Chinese patent medicine of special for treating constipation is to overcome above-mentioned deficiency.
For achieving the above object, characteristics of the present invention are: it is the medicament of being made by following weight ratio proportion raw material:
Rhizoma Atractylodis Macrocephalae 8-15 part Herba Cistanches 5-10 part Radix Angelicae Sinensis 3-9 part
Fructus Aurantii Immaturus 2-8 part Fructus Mori 2-8 part Aloe 1-4 part.
The wherein a kind of raw material weight ratio proportioning that constitutes above-mentioned medicament is:
6.8 parts of 8.4 parts of Radix Angelicae Sinensis of 11.84 parts of Herba Cistanches of the Rhizoma Atractylodis Macrocephalae
2.6 parts of 5.08 portions of Aloes of 5.08 portions of Fructus Moris of Fructus Aurantii Immaturus.
The wherein another kind of raw material weight ratio proportioning that constitutes above-mentioned medicament is:
6.5 parts of 6.5 parts of Radix Angelicae Sinensis of 8.4 parts of Herba Cistanches of the Rhizoma Atractylodis Macrocephalae
1.5 parts of 3.2 portions of Aloes of 3.8 portions of Fructus Moris of Fructus Aurantii Immaturus.
The third raw material weight ratio proportioning that constitutes above-mentioned medicament is:
4.5 parts of 8.56 parts of Radix Angelicae Sinensis of 12.85 parts of Herba Cistanches of the Rhizoma Atractylodis Macrocephalae
3 parts of 2.25 portions of Aloes of 2.5 portions of Fructus Moris of Fructus Aurantii Immaturus.
The Chinese medicine of above-mentioned treatment constipation can also add the correctives of drug excipient or medicine.Drug excipient can be one or more the combination in sucrose, starch, magnesium stearate, sorbitol, microcrystalline Cellulose, micropowder silica gel, the carboxymethyl starch sodium, with granule or tablet or the capsule that medication preparation of the present invention is become to be convenient to take.The medicine correctives can be one or more the combination in steviol glycosides, Oligomeric maltose, lactose, the edible essence, so that prepared medicament has good sweet felling, after overcoming number flavor Chinese herbal medicine compatibility, the five tastes mix, the salty drawback of having a nasty taste of bitter peppery acid.The coating of medicine can be a kind of in film-coat, semi-film coating, the enteric coating etc., to reach moistureproof, reduce bad smell, to alleviate gastric irritation or the effect being destroyed and reach attractive in appearance, easily take by gastric juice.
Certainly; aforementioned pharmaceutical compositions of the present invention process of Chinese medicine preparation routinely can be prepared into any pharmaceutical dosage form that is suitable for using clinically; for example: tablet; powder; granule; capsule; pill; unguentum; mixture; syrup; injection; the card agent; liniment; suppository etc.; as long as use pharmaceutical composition of the present invention; no matter adopt which kind of dosage form; all belong within protection scope of the present invention; when aforementioned pharmaceutical compositions is prepared into medicament; special requirement according to preparation; the excipient that can add other again, for example: flavoring agent; solubilizing agent; suspensoid; diluent; disintegrating agent; lubricant etc.The preferred dosage form of the present invention is granule, tablet, oral liquid.
Medicine of the present invention can all be ground into fine powder with medical material in the preparation, fill with capsule then and make capsule, perhaps in fine powder, add material that Mel or syrup or starch slurry etc. have certain viscosity as binding agent, conventional dosage forms such as make granule or tablet or cream, pellet, ball, loose.
The shortcoming of above method is that direct preparations shaping does not cause the invalid components in the preparation more to medical material through extracting, taking dose is bigger, in addition, dosage form is tradition relatively, be difficult to embody the target of " triple effect (efficient, quick-acting, long-acting); three little (dosage is little, toxicity is little, side effect little), five convenience (produce, transport, preserve, carry, take) " this modern traditional Chinese patent medicine exploitation.
For this reason, we provide the another kind of preparation method of medicine of the present invention: above Six-element, and it is standby that Aloe powder is broken into fine powder; All the other five tastes waters and/or ethanol extract, and after the extracting solution natural subsidence, get supernatant concentration and become clear paste, and drying is pulverized; With dried cream powder and Aloe fine powder mixing, add suitable adjuvant and make clinical receivable dosage form.
This method is extracted the other medicines except that Aloe, thereby has assembled effective ingredient, has removed invalid components, and wherein extracting used solvent can be water, also can be ethanol, can also the two all use; The extraction that five kinds of medical materials can be mixed can also with five kinds of medical materials separately adopt different solvents to extract.In a word, the mode of extraction can be varied, mainly is based on the polarity size and the dissolubility size in solvent of active substance in the medical material of respectively distinguishing the flavor of.If the employing ethanol extraction, then generally adopting concentration is the ethanol of 50%-90%, and the method for extraction is that dipping or hot reflux all can.
The present invention also provides a kind of and has extracted preferably, the method for preparations shaping, and this method is: above Six-element, and it is standby that Aloe powder is broken into fine powder; Water boiling and extraction 2 times of all the other five tastes, each 2 hours, filter, merging filtrate, standing over night is got supernatant, is condensed into clear paste, and drying is pulverized; With dried cream powder and Aloe fine powder mixing, add starch and make the piller that particle diameter is 0.4-1.2mm with 75% ethanol, fill with capsule behind the bag film-coat.
Its function of medicine of the present invention cures mainly and is: tonifying speen and tonifying kidney, loosening bowel to relieve constipation.Be used for constipation due to deficiency syndrome, disease sees that constipation or defecation are weak, lusterless complexion or sallow, and Mental fatigue is breathed hard, and has a dizzy spell soreness of the waist and knees, pale tongue with white fur, thready pulse or thin and delicate etc.
According to clinical findings, the human body chronic constipation mostly is constipation due to insufficiency, is that the qi-blood-body fluid large intestine that is difficult to make moist makes so.Right large intestine is under the jurisdiction of taste, relies transporting and transforming function of the spleen and stomach, transmission body fluid foster to moisten, and occupies the institute department of lower abdomen for part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels Liver and kidney.Or the dysfunction of the spleen, transfer not normally, body fluid oozes partially, does not moisten large intestine; Or deficiency of the liver and kindey, essence and blood loses empty, be difficult to moisten large intestine, so that dryness of the intestine and dry and hard stool does and do not draw, and the card of chronic constipation then takes place; Or constipation with the passing of time feel frustrated the consumption Tianjin, form simulataneous insufficiency and excessive.Lee east permanent so-called " the old deficiency of vital energy, deficiency of body fluid being arranged and the dryness accumulated in the stomach and intestine person " promptly belongs to this type of.So control suitable tonifying speen and tonifying kidney, kidney essense nourishes blood, assistant is with the circulation of qi promoting relieving constipation, and this mark is taken into account.
Among the we with Rhizoma Atractylodis Macrocephalae spleen invigorating, one with in, multiple its transfers the normal function of body fluid; One with ridging, Gu its source that day after tomorrow, essence and bloodization was given birth to is to be principal agent.With Herba Cistanches replenishing essence the kidney invigorating, and with intestine moistening; Invigorate blood circulation with the accent liver with Chinese Angelica blood replonishing, and the wind-dryness that removes large intestine is ministerial drug altogether, with Fructus Mori nourish liver and kidney, promoting generation of vital essence and blood, to help the merit of Herba Cistanches, Radix Angelicae Sinensis; Spreading of right essence and blood, intestinal internal organs unobstructed depends on the popular of gas in fact, so with the Fructus Aurantii Immaturus circulation of qi promoting, smooth regulating QI machine moistens the cloth the intestines and stomach with popular essence and blood, more lets out with delaying of a small amount of Aloe, helps not passing of loosening bowel to relieve constipation, more than be adjuvant drug altogether.So this mark is taken into account, and is secret just, solid but tonneau is tied source just, also can must mend because of QI and blood, intestinal is done for oneself general because of profit internal organs gas.All medicines and closing are played the effect of tonifying speen and tonifying kidney, loosening bowel to relieve constipation altogether.
Animal experiment carries out from following three aspects before clinical: one, must influence traditional Chinese medical science constipation model; Two, absorb to such an extent that influence to intestinal movement function Heshui part; Three, must influence partial immunity index and physical ability.
One, must influence traditional Chinese medical science constipation model:
With the theory of Chinese medical science is guidance, utilizes dry foodstuff and self fecal suspension to cause constipation of mice dryness accumulated in the stomach and intestine and excess-heat constipation model respectively, and observation once gavages medicine and gets defecating feces excretion.Each 120 modeling mice of each model, be divided into the high, medium and low metering group of this medicine immediately by sex, Fructus Cannabis Bolus matched group, phenolphthalein tablet matched group and normal saline matched group, dosage be respectively 3.0g/Kg, 1.5g/Kg, 0.75g/Kg (this medicine gets consumption and calculates by crude drug, below test all with), 3g/Kg Fructus Cannabis Bolus and 0.033g/Kg phenolphthalein tablet and 0.4ml/10g normal saline.Medicine of the present invention as a result can make dryness accumulated in the stomach and intestine constipation, excess-heat mice with constipation defecation grain digital display work increase, and high dose group has facilitation to excess-heat mice with constipation defecation, and its effect is better than waiting dosage Fructus Cannabis Bolus group.
Two, must influence intestinal movement function and moisture absorption:
1, must influence the mouse intestinal fltting speed:
120 of mices, group technology and dosage are the same, observe administration after 20 minutes the charcoal end at intestinal propulsion percentage rate and charcoal end efflux time.The result shows that medicine of the present invention can increase intestinal propulsion speed, improves the charcoal end and advances percentage rate, and shorten the charcoal end eliminating time, and its effect is approximate with reference substance Fructus Cannabis Bolus and phenolphthalein tablet.
2, to the influence of isolated ileum segments in guinea pigs wriggling function:
96 of Cavia porcelluss, group technology is the same, respectively gets the 2cm ileal segment and puts in the bath, add 5%, 10% and 20% this medicine suspension 0.1ml respectively, 25% Fructus Cannabis Bolus suspension 0.1ml, 10% phenolphthalein tablet suspension 0.1ml and normal saline 0.1ml, record ileal segment contraction frequency and tensile variation and feature thereof.The result shows, medicine of the present invention can make exsomatize ileum contraction frequency and tension force increase, and is dose dependent, behind Fructus Cannabis Bolus short time increase frequency and the tension force, descend rapidly, and the contraction characteristics of medicine group of the present invention show that its effect has characteristics gentle and that continue.
3, to the influence of Cavia porcellus at body ileum contractile function:
66 of Cavia porcelluss, group technology is the same, adopts the ileal segment suspension method, the variation of record administration after-contraction tension force, contraction intensity, contraction frequency, intestinal segment vigor.The result shows this medicine obviously contraction intensity and intestinal segment vigor.
4, to the influence of mice intestinal segment moisture absorption
The result shows that medicine of the present invention does not have obvious influence to mouse small intestine moisture absorption function, and administration 4,5 hours mice large intestine moisture is absorbed with obvious inhibitory action, and Fructus Cannabis Bolus is to small intestinal.Big intestinal absorption all has obvious consistent acting on.
Three, to the influence of immunologic function and physical ability
1, to effect of immunologic function:
100 of mices are divided into the high, medium and low dosage group of this medicine, Radix Astragali matched group immediately.The normal saline matched group, each organizes 20, male and female half and half, the dosage of invention medicine is with test one, Radix Astragali consumption is 5g/Kg, normal saline is 0.5ml/20g, makes lymhocyte transformation rate respectively and measures (revulsion in the body), mice hemolytic antibody mensuration, NK cytoactive mensuration and thymus index mensuration.The result shows that this invention medicine can improve mouse lymphocyte and transform, and promotes the generation of hemolytic antibody in the mice body, increases the NK cells in mice activity, improves the mouse thymus index, shows that its pair cell and humoral immunization all have the improvement effect, acts on similar to the Radix Astragali.
2, the tired influence of mice swimming:
100 of mices are divided into the high, medium and low metering group of this medicine, Radix Astragali matched group, tap water matched group immediately, and 20 every group, equal male and female half and half.Dosage is with test one.Medication is heavy burden method do swimming fatigue test after 15 days.The result shows that the high, medium and low dosage of medicine of the present invention can obviously prolong the tired time of mice swimming, acts on similar to the Radix Astragali.
The specific embodiment
The present invention is described in detail below in conjunction with embodiment, but should not be construed as limitation of the present invention.
Embodiment 1:
Get Rhizoma Atractylodis Macrocephalae 11.84Kg, Herba Cistanches 8.4Kg, Radix Angelicae Sinensis 6.8Kg, Fructus Aurantii Immaturus 5.08Kg, Fructus Mori 5.08Kg, Aloe 2.6Kg.Be ground into fine powder, sieve, mixing adds an amount of refined honey and makes big honeyed pills or small honey pill.
The present invention's pill has the function of tonifying speen and tonifying kidney, loosening bowel to relieve constipation.Be used for constipation due to deficiency syndrome, disease sees that constipation or defecation are weak, lusterless complexion or sallow, and Mental fatigue is breathed hard, and has a dizzy spell soreness of the waist and knees, pale tongue with white fur, thready pulse or thin and delicate etc.
Embodiment 2:
Get Rhizoma Atractylodis Macrocephalae 8.4Kg, Herba Cistanches 6.5Kg, Radix Angelicae Sinensis 6.5Kg, Fructus Aurantii Immaturus 3.8Kg., Fructus Mori 3.2Kg, Aloe 1.5Kg.It is standby that Aloe powder is broken into fine powder; All the other five tastes are earlier with 60% alcohol reflux twice, and each 2 hours, medicinal liquid reclaimed ethanol and concentrates and is clear paste, and medicinal residues continue to decoct with water twice, and each 2 hours, to filter, filtrate is condensed into clear paste; Merge two kinds of clear paste,, make granule with suitable amount of sucrose powder mixing, drying, promptly.
When taking, the present invention's granule uses mixing in water for oral taking, each 5 grams, every day 2 times.
Embodiment 3:
Get Rhizoma Atractylodis Macrocephalae 12.85Kg, Herba Cistanches 8.56Kg, Radix Angelicae Sinensis 4.5Kg, Fructus Aurantii Immaturus 2.5Kg, Fructus Mori 2.25Kg, Aloe 3Kg.It is standby that Aloe powder is broken into fine powder; All the other medical materials decoct with water and extract 2 times, and each 2 hours, filter, merging filtrate, standing over night is got supernatant, is condensed into clear paste, and drying is pulverized; With dried cream powder and Aloe fine powder mixing, add starch and make the piller that particle diameter is 0.4-1.2mm with 75% ethanol, fill with capsule behind the bag film-coat.
This product is taken 3 at every turn, every day 2 times.The treatment and the controlled observation of 409 examples show that the produce effects cure rate of its treatment constipation is 75.7%, and total effective rate is 94.6%, and its total curative effect is better than contrasting the drug anesthesia cannabis capsule.